纤维蛋白原浓缩物在创伤相关出血中的应用：系统评价和荟萃分析。

Use of fibrinogen concentrate for trauma-related bleeding: A systematic-review and meta-analysis.

机构信息

From the Department of Critical Care (S.N.S.), and Department of Pharmacy Services (S.N.S.), Surrey Memorial Hospital, Surrey, British Columbia; and Department of Emergency Medicine (S.S.L., A.K., E.N.V.), and Department of Critical Care (A.K., E.N.V.), University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

J Trauma Acute Care Surg. 2020 Dec;89(6):1212-1224. doi: 10.1097/TA.0000000000002920.

DOI:10.1097/TA.0000000000002920

PMID:32890340

Abstract

BACKGROUND

Trauma-induced coagulopathy contributes to significant morbidity and mortality in patients who experience trauma-related bleeding. This study aimed to synthesize the evidence supporting the efficacy and safety of preemptive and goal-directed fibrinogen concentrate (FC) in the management of trauma-related hemorrhage.

METHODS

PubMed, Medline, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform were systematically searched. All trial designs, except individual case reports, which evaluated the preemptive or goal-directed use of FC for trauma-related bleeding/coagulopathy, in patients older than 16 years, were included in the systematic review. For the included randomized controlled trials comparing FC with control, meta-analysis was performed and a risk-of bias-assessment was completed using the Cochrane Methodology and Preferred Reporting Items Systematic Reviews and Meta-analysis guidelines.

RESULTS

A total of 2,743 studies were identified; 26 were included in the systematic review, and 5 randomized controlled trials (n = 238) were included in the meta-analysis. For the primary outcome of mortality, there was no statistically significant difference between the groups, with 22% and 23.4% in the FC and comparator arms, respectively (risk ratio, 1.00 [95% confidence interval, 0.39 to 2.56]; p = 0.99). In addition, there was no statistical difference between FC and control in packed red blood cell, fresh frozen plasma, or platelet transfusion requirements, and thromboembolic events. Overall, the quality of evidence was graded as low to moderate because of concerns with risk of bias, imprecision, and inconsistency.

CONCLUSION

Further high-quality, adequately powered studies are needed to assess the impact of FC in trauma, with a focus on administration as early as possible from the point of entry into the trauma system of care.

LEVEL OF EVIDENCE

Systematic review and Meta-analysis, level II.

摘要

背景

创伤引起的凝血功能障碍导致创伤相关出血的患者出现显著的发病率和死亡率。本研究旨在综合支持预先和目标导向纤维蛋白原浓缩物（FC）在创伤相关出血管理中的疗效和安全性的证据。

方法

系统检索了 PubMed、Medline、EMBASE、Web of Science、Cochrane 系统评价数据库、Cochrane 对照试验中心注册库、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台。系统评价纳入了所有试验设计，除了个体病例报告，这些报告评估了 FC 在 16 岁以上的创伤相关出血/凝血障碍患者中的预先或目标导向使用。对于比较 FC 与对照组的随机对照试验，进行了荟萃分析，并使用 Cochrane 方法学和首选报告项目系统评价和荟萃分析指南完成了风险偏倚评估。

结果

共确定了 2743 项研究；系统评价纳入了 26 项研究，荟萃分析纳入了 5 项随机对照试验（n=238）。对于死亡率这一主要结局，两组之间没有统计学上的差异，FC 组和对照组的死亡率分别为 22%和 23.4%（风险比，1.00[95%置信区间，0.39 至 2.56]；p=0.99）。此外，FC 与对照组在需要输注浓缩红细胞、新鲜冷冻血浆或血小板以及血栓栓塞事件方面没有统计学差异。总体而言，由于对偏倚风险、不精确性和不一致性的担忧，证据质量被评为低至中度。